Clinical Trial: Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Treatment of of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells. A Phase III Randomized Open Label Multi-center Study in Southern China.
Brief Summary: Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.
Detailed Summary:
Sponsor: Guangdong General Hospital
Current Primary Outcome: Proportion of patients responding to treatment of cGvHD with MSC [ Time Frame: 90 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall survival [ Time Frame: 2 year ]
- Progression-free survival [ Time Frame: 2 year ]
- Time without systemic immunosuppression [ Time Frame: 2 year ]
- Cumulative incidents of non-relapse mortality [ Time Frame: 2 year ]
- Adverse events [ Time Frame: 2 year ]
Original Secondary Outcome: Same as current
Information By: Guangdong General Hospital
Dates:
Date Received: November 5, 2014
Date Started: October 2014
Date Completion: December 2019
Last Updated: November 11, 2014
Last Verified: November 2014
